BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALL

    MDR report key: 24414753 · Received February 23, 2026

    Report

    Report Number
    1017294-2026-00021
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 28, 2026
    Report Date
    March 13, 2026
    Manufacturer
    CONMED
    Product Code
    GFA
    UDI-DI
    10845854006382
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT BEING RETURNED AND THE PHOTOGRAPHIC EVIDENCE PROVIDED DOES NOT APPEAR TO VERIFY THE COMPLAINT; THEREFORE, A DEVICE MALFUNCTION CAN NOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF ONE DEVICE FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 21 COMPLAINTS, REGARDING 21 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 1,726,314 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.00001. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO NEVER PINCH THE HALL PRIMECUT CASSETTES. OVERHEATING OF THE BLADE MAY CAUSE DAMAGE TO THE CASSETTE AND MAY CAUSE BURNS OR THERMAL NECROSIS. AVOID CONTACT OF BLADES WITH CUTTING BLOCKS, RETRACTORS OR OTHER INSTRUMENTATION. DAMAGE TO BLADE OR INSTRUMENTATION MAY OCCUR. METAL FRAGMENTS MAY CAUSE INJURY TO PATIENT OR USER. DO NOT USE BURS FOR PLUNGE CUTTING. INJURY OR DAMAGE MAY OCCUR. WHEN USING THE POWERPRO SAGITTAL SAW ATTACHMENT (PRO2043), PLACING EXCESSIVE BENDING OR TWISTING FORCE ON THE SAGITTAL SAW BLADE MAY CAUSE THE COLLET TO OPEN AND RELEASE THE SAW BLADE. DO NOT USE SAW BLADES TO PRY, REMOVE BONE GRAFTS, OR AS A LEVERAGE POINT. DO NOT APPLY EXCESSIVE BENDING OR TWISTING FORCE TO BLADE. PATIENT OR USER INJURY MAY OCCUR. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE THAT THE 00507116100 OSCILLATOR BLADE, 25.4 X 90 X 1.27 MM (.050") DEVICE WAS BEING USED ON (B)(6) 2026 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿TODAY WE HAD A 5071-161 BREAK FROM LOT 1506918.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND WAS REMOVED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE 00507116100 OSCILLATOR BLADE, 25.4 X 90 X 1.27 MM (.050"), DEVICE WAS BEING USED ON (B)(6) 2026 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿TODAY WE HAD A 5071-161 BREAK FROM LOT: 1506918.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND WAS REMOVED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464397 HALL BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA CONMED 1506918 10845854006382

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown